Australia Licensed Pharmacovigilance Specialist

Job Summary

Acting as the primary local representative for Pharmacovigilance and Regulatory Affairs, the full-time Australia Licensed Pharmacovigilance Specialist will ensure compliance with national regulations, manage communications with the Marketing Authorisation Holder and local authorities, and oversee local pharmacovigilance activities remotely.

Key responsibilities

• Communicate promptly and effectively with the Marketing Authorisation Holder and local regulatory authorities
• Manage local regulatory intelligence, including the collection and reporting of suspected adverse drug reactions
• Support the development and implementation of local pharmacovigilance systems in compliance with global and local regulations

Required qualifications

• Bachelor's Degree in Life Sciences, Chemistry, Nursing, or equivalent professional experience
• At least 3 years of pharmacovigilance or safety-related experience in a pharmaceutical, CRO, or regulatory environment
• Good understanding of ICH GVP and local pharmacovigilance requirements
• Experience in case handling, literature screening, or local pharmacovigilance activities is preferred
• Proficiency in English; knowledge of additional languages is advantageous